Re-Fine Bright 10kg, V Pink

by Yamahachi Dental Mfg., Co.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD080XXRFB10KGXXVPN0 UDI-DI	Date9 Jul 2019Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Re-Fine Bright
Generic Name: Dental prosthesis restorative material, unfilled resin
Model / Reference: 10KG, V PINK

Primary DI / UDI-DI: D080XXRFB10KGXXVPN0
510(k) Number: K131036
FDA Product Code: EBI
GMDN Term: Dental prosthesis restorative material, unfilled resin

Device Class: Class II
Regulation Number: 872.3760
GUDID distribution status: In Commercial Distribution

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Properties

Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (10)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No